NCT05766566 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Mizuno H, Zuk PA, Zhu M, Lorenz HP, Benhaim P, Hedrick MH
Myogenic differentiation by human processed lipoaspirate cells. Plast Reconstr Surg. 2002 Jan;109(1):199-209; discussion 210-1. doi: 10.1097/00006534-200201000-00030.
Rius J, Nessim A, Nogueras JJ, Wexner SD
Gracilis transposition in complicated perianal fistula and unhealed perineal wounds in Crohn's disease. Eur J Surg. 2000 Mar;166(3):218-22. doi: 10.1080/110241500750009311.
Ruffolo C, Citton M, Scarpa M, Angriman I, Massani M, Caratozzolo E, Bassi N
Perianal Crohn's disease: is there something new? World J Gastroenterol. 2011 Apr 21;17(15):1939-46. doi: 10.3748/wjg.v17.i15.1939.
Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ
The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.
Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH
Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

Treatment of Perianal Fistulas in Crohn's Disease With Autologous Microfragmented Adipose Tissue With the Lipogems® System

Clinical trial NCT05766566 - References